PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW

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1 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf) and are provided with free text boxes to elaborate on their assessment. These free text comments are reproduced below. ARTICLE DETAILS TITLE (PROVISIONAL) AUTHORS Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicenter randomised trial the EOLE Study Protocol. Barasinski, Chloé; VENDITTELLI, FRANÇOISE VERSION 1 - REVIEW REVIEWER REVIEW RETURNED Carcopino Department of obstetrics and gynecology Hopital Nord - APHM Marseille, France 14-May-2016 GENERAL COMMENTS This study is highly relevant for routine clinical practice, well designed and presented. My only concern would be regarding the calculation of the number of patients to be included. It is questionable whether the choice of a 20% difference in the primary endpoint between the two groups might be to big a difference. Performing such a study, the authors should consider the possibility to include a larger number of patients and therefore being able to identify a smaller difference (such as 10%). REVIEWER REVIEW RETURNED Marianne Prins Midwifery Academy of Amsterdam and Groningen, Amsterdam, the Netherlands. 11-Aug-2016 GENERAL COMMENTS Numbers refer to the items in the checklist above: 1. The objective is to assess and compare the effectiveness of the different pushing methods. Suggestion is to include the primary outcome of the study in the background. 2. Good to add information on the study population and (the timing of) the randomization in the abstract. 4. Exclusion criteria are those that may justify emergency delivery. Are women with diabetes mellitus or (pre existent) hypertension without proteinuria or obesity excluded or included. Are women with a fourth degree tear in history included or excluded? Is there a list with the most common exclusion criteria to be sure all centers use the same criteria? The instruction for the open glottis group could be completed with: 'make a sound while exhaling, like oh or ah'.

2 When do the professionals start with coaching: immediate after full dilatation is diagnosed or when the women feels the urge to push? This is also important for the participants who use epidural analgesia. If the midwife decides this can affect the internal validity of the study. Blood loss within 24 hours after delivery; how do you get reliable results? Do you register the duration of the second stage? Midwives and professionals teaching childbirth preparation are trained. How about the obstetricians, student doctors and midwives? How do you monitor the adherence to the intervention? Procedure to measure the umbilical artery ph is missing. Is there a description of the questionnaires voor POP, Incontinence and women's satisfaction regarding their validity and reliability? Where can the protocols be found? 6. The principal endpoint is defined inconsistently. Spontaneous delivery without perineal lesion but also described and extended with other variables like: obstetric maneuvres, postpartum hemorrhage < 500ml, apgar score > 9, and episiotomy missing in the definition. Obstetric maneuvers is not defined. To collect data about the women's perception of her pelvic floor function the assessor needs to be blinded for the pushing method, how do you do that? Which data do you collect data when women discontinue the study? How do you stimulate data quality (e.g, double data entry, range checks for data values)? 7. Analysis of the questionnaires is missing. Satisfaction of the women is missing. 8. The background could benefit of more profound evidence for describing hemodynamic and respiratory changes during inhalation and pushing. What is the level of evidence of ' constipations solutions'? The timeline of the EOLE study misses some specifications. Information to women is given at xxx weeks pregnancy. Training on types of pushing is between xx and xx weeks pregnancy. Informed consent is given at xxx weeks pregnancy etc etc. VERSION 1 AUTHOR RESPONSE Reviewer: 1 Reviewer Name: X Carcopino Institution and Country: Department of obstetrics and gynecology, Hopital Nord - APHM, Marseille,

3 France Competing Interests: none declared This study is highly relevant for routine clinical practice, well designed and presented. My only concern would be regarding the calculation of the number of patients to be included. It is questionable whether the choice of a 20% difference in the primary endpoint between the two groups might be to big a difference. Performing such a study, the authors should consider the possibility to include a larger number of patients and therefore being able to identify a smaller difference (such as 10%). On the one hand, we chose not to conduct an equivalency study, and on the other, the efficacy of placebo in this situation is considered to be around 30%. We had a discussion with midwives and doctors before finalizing the protocol. It was consensually decided that a threshold of 20% would be clinically relevant and would enable us to draft guidelines for both women and professionals. The midwives and obstetricians consulted did not consider that a difference of 10% was sufficient to justify the choice of a type of pushing as a standard of care. Reviewer: 2 Reviewer Name: Marianne Prins Institution and Country: Midwifery Academy of Amsterdam and Groningen, Amsterdam, the Netherlands. Competing Interests: None declared. 1. The objective is to assess and compare the effectiveness of the different pushing methods. Suggestion is to include the primary outcome of the study in the background. We have made the correction requested. 2. Good to add information on the study population and (the timing of) the randomization in the abstract. We have added this information to the abstract. 4. Exclusion criteria are those that may justify emergency delivery. Are women with diabetes mellitus or (pre existent) hypertension without proteinuria or obesity excluded or included. Are women with a fourth degree tear in history included or excluded? Is there a list with the most common exclusion criteria to be sure all centers use the same criteria? The list of exclusion criteria is the one detailed in the article. Women with diabetes mellitus or (preexistent) hypertension without proteinuria or obesity or a fourth degree tear in their obstetric histories can be included. The 2012 French national guideline about planned caesarean deliveries [Haute Autorité de Santé (HAS): Recommandations de bonne pratique. Indications de la césarienne programmée à terme (in French). Paris: HAS Press; programmée-a-terme] authorises vaginal

4 deliveries for women with fourth-degree tears who so choose. All the included and excluded diseases are clearly defined in the protocol. We have recorded all pertinent data in our electronic case report form so that they can be included, if relevant, in our logistic regression analysis. Because of the word limits, some details from the protocol have been omitted from the article. The instruction for the open glottis group could be completed with: 'make a sound while exhaling, like oh or ah'. Yes. This is why this protocol, unlike other publications on the subject, specifies that both the women and the midwives-investigators must undergo standardised training about the types of pushing. We thus developed two training films: one for the pregnant women and the other for the professionals. When do the professionals start with coaching: immediate after full dilatation is diagnosed or when the women feels the urge to push? This is also important for the participants who use epidural analgesia. If the midwife decides this can affect the internal validity of the study. Because this is a pragmatic study, each investigator decides when pushing begins. A large majority of women in France have epidural analgesia during labour, so the beginning of pushing is generally delayed. Immediately pushing at full dilatation is not the standard policy in France. A French national database shows that the length of the passive second stage of labour has increased during the last 10 years (http://www.audipog.net/interro-choix.php). Of course, in cases of abnormal FHR, women can be asked to push early. Investigators are collecting the station of the descending fetus at the beginning of pushing. In addition, all women in France have continuous FHR monitoring during the second stage. Blood loss within 24 hours after delivery; how do you get reliable results? An updated (2014) French national guideline defines immediate PPH [http://www.cngof.fr/pratiquescliniques/recommandations-pour-la-pratique-clinique?folder=rpc%2bcollege]. Moreover, under the aegis of the French national authority for health (HAS), French maternity units are required to audit records randomly selected at the national level from hospital discharge data, to analyse the prevention and management of immediate PPH based on five indicators, validated in advance [http://www.has sante.fr/portail/jcms/c_ /fr/ipaqss-2015-mco-outils-necessaires-aurecueil-des-indicateurs-du-theme-prevention-et-prise-en-charge-initiale-de-l-hemorragie-du-postpartum-immediat-pp-hpp]. The results of this audit, associated with other indicators, can affect the funding levels for hospitals [Decree dated 5 August 2016, setting the methods of calculating funding of healthcare facilities for the application of article L ]. Moreover, perinatal networks cover all of France, and one of their functions is to monitor various perinatal indicators, including those selected by the Euro-Peristat group (Euro-Peristat Perinatal Health Indicators: european-perinatal-health-report-2010.html), some of which are associated with immediate PPH (maternal mortality rate, maternal mortality rate by obstetric causes, prevalence of severe maternal morbidity), while others are more specific (severe PPH hemorrhages,

5 etc.). In conclusion, French physicians are clearly aware of the importance of estimating blood loss [see Vendittelli F et al. Policies for management of postpartum haemorrhage: the Hera cross-sectional study in France. Eur J Obstet Gynecol. Reprod Biol 2016;205:21-26]. Do you register the duration of the second stage? Yes, we do. Midwives and professionals teaching childbirth preparation are trained. How about the obstetricians, student doctors, and midwives? In this protocol, all the investigators are midwives, and the study preparation began by training them. All obstetricians in each unit are aware of the study in some detail and can thus inform the women during antenatal care appointments and respond to relevant questions. In French public maternity units, midwives are responsible for normal deliveries. They call for an obstetrician in cases of abnormal labour or delivery. The student midwives are supervised by senior midwives. How do you monitor the adherence to the intervention? Compliance with the allocated intervention is monitored (number of contractions, type of pushing for each contraction, number of pushes per contraction). After the delivery, the investigator immediately completes an electronic case report form so that compliance can be analysed. Procedure to measure the umbilical artery ph is missing. The umbilical artery ph measure is the same in all French hospitals. A French national guideline for Methods of fetal monitoring during labour" was issued in 2007 [http://www.cngof.fr/pratiquescliniques/recommandations-pour-la-pratique-clinique?folder=rpc%2bcollege]. There is no difficulty in measuring umbilical artery ph in French hospitals; equipment is available and the staff are trained. The availability of a ph machine for all deliveries is evaluated regularly by the insurance companies of healthcare facilities with maternity wards. Is there a description of the questionnaires voor POP, Incontinence and women's satisfaction regarding their validity and reliability? Where can the protocols be found? In our protocol, the principal reference about the POP-Q and the ICIQ-SF are available in the article (references 17 and 18). Both questionnaires had been validated. The women s satisfaction questionnaire (the only one available in French to assess women s satisfaction about their delivery) was developed at the maternity unit of Geneva (Switzerland) University Hospital, and we participated in its validation. An article about it has been submitted for publication.

6 The principal endpoint is defined inconsistently. Spontaneous delivery without perineal lesion but also described and extended with other variables like: obstetric maneuvres, postpartum hemorrhage < 500ml, apgar score > 9, and episiotomy missing in the definition. Obstetric maneuvers is not defined. The principal endpoint is consistently described. The principal and secondary endpoints had been well described page 10 and 11. The principal endpoint will be a composite criterion: spontaneous delivery without perineal lesion (no episiotomy or second, third, or fourth degree lacerations). Our secondary outcome measures are divided into three categories...finally, for both mother and child, a composite endpoint for mother and child will be: uncomplicated birth defined by birth without cesarean and without operative intervention or obstetrical manoeuvres, without postpartum hemorrhage [500 ml], without second, third, or fourth degree perineal lacerations, and with a 5-min Apgar 9. We note that the final secondary endpoint has previously been published to define a lowrisk population. That is, it might better be considered a quality indicator than an endpoint. We also note that the episiotomy or tear may be first-degree, second degree, third-degree or fourth-degree laceration [cf. Symonds EM, Symonds IM. Essential Obstetrics and Gynaecology, fourth edition, 2004]. The obstetric manoeuvres included manoeuvres for shoulders dystocia, internal cephalic version, total breech extraction, etc. These definitions are well described and commonly used in France, as shown in the Audipog database [http://www.audipog.net/]. Performance (and success or failure) of each separate manoeuvre will be recorded and available for analysis. To collect data about the women's perception of her pelvic floor function the assessor needs to be blinded for the pushing method, how do you do that? The pelvic floor function is evaluated with the ICIQ-SF, which is a self-administered questionnaire. The women are of course not blinded to the allocated pushing technique, but they normally have no opinion or preference: if they did, they would probably not agree to be randomised. Which data do you collect data when women discontinue the study? The study is an intention-to-treat study. Loss-to-follow-up can only occur after hospital discharge. We will therefore be able to collect all the medical data about medical history, delivery, and postpartum hospitalization. Loss to follow-up will be a problem only for 2 secondary objectives (satisfaction and pelvic floor assessment).

7 How do you stimulate data quality (e.g, double data entry, range checks for data values)? All of the information required by the protocol must be entered into the electronic CRF. The relevant information will be recorded as it is obtained and transcribed clearly and legibly into the electronic notebook. This electronic data collection notebook has built-in quality control features to ensure the quality of the data entry as well as range checks for data values. This electronic record will be available by secure access on the website, so that the investigator-coordinator can remotely oversee the records of the maternity units participating in the study. Only one research midwife collects the data (except for data about compliance with the allocated intervention, and about the maternal pelvic floor). Moreover: - The investigator undertakes to conduct this study in compliance with Good Clinical Practices and French public health law [Act n dated 9 August 2004 concerning biomedical research, its implementing decree n dated 26/04/2006, which modifies the portion of the Public Health Code (specifically, Part 1, Book 1, Title II, Section 1) concerning biomedical research, as well as the decrees in force]. The investigator also undertakes to conduct this research in accordance with Declaration of Helsinki of the World Medical Association (Tokyo 2004, as revised). - The investigator-coordinator appointed by the sponsor will ensure the appropriate performance of the study, of the collection of data generated in writing, their documentation, recording, and reporting, in accordance with the standard operating procedures of the Clermont-Ferrand University Hospital Centre and in compliance with Good Clinical Practices and with the applicable legislative and regulatory provisions. The investigators guarantee the authenticity of the data collected in this study and accept the legal provisions authorizing the study sponsor to set up quality control procedures. The investigatorcoordinator and all other investigators therefore agree to make themselves available for quality control inspections that will be conducted at regular intervals in the maternity units, by the investigatorcoordinator. During these visits, the following items will be checked: - Informed consent, - Compliance with the research protocol and the procedures defined therein, - Assurance of the quality of the data collected in the electronic CRF: accuracy, missing data, consistency of the data with the source documents (such as paper and electronic medical files and questionnaires completed by the midwives). 7. Analysis of the questionnaires is missing. Satisfaction of the women is missing. We have corrected this omission. 8. The background could benefit of more profound evidence for describing hemodynamic and respiratory changes during inhalation and pushing. What is the level of evidence of ' constipations solutions'?

8 The point of the study is that good evidence is lacking to describe hemodynamic and respiratory changes for each type of pushing. Accordingly, there is not adequate evidence on which to choose the best type of pushing for neonatal outcome. As the publication of de Gasquet is in French, we have changed the reference to the publication of Shafik et al. (2003; n=46). The timeline of the EOLE study misses some specifications. Information to women is given at xxx weeks pregnancy. Training on types of pushing is between xx and xx weeks pregnancy. Informed consent is given at xxx weeks pregnancy etc etc. During prenatal care visits, women are informed about the study by posters hung in maternity units and midwives' offices. They are instructed about the types of pushing during one of their childbirth preparation and parenthood classes (at either the hospital or organized privately by midwives). The national health insurance fund covers 8 prenatal sessions of at least 45 minutes. The contents of these training sessions are based on a HAS guideline issued in 2005 [http://www.hassante.fr/portail/upload/docs/application/pdf/preparation_naissance_recos.pdf]. These sessions begin in France during the 7th month of gestation and are completed during the 9th month. [http://www.ameli-sante.fr/fileadmin/mediatheque/pdf/guide_naissance_01.pdf]. As part of this study, during these childbirth preparation and parenthood classes between 29 and 37 week s gestation, pregnant women receive instruction created specifically for the study, in the form of a video on the two types of directed pushing evaluated in the study. They also receive a written brochure about the study. Moreover, those who have completed this instruction receive a card attesting to this instruction, which they are asked to keep with their blood group cards (to minimize the possibility of losing it). This information is also included in their paper obstetrics file and in their electronic file, in the section "action to be taken". We have modified Figure 1, as the editor requested, and replaced it by a more precise schematic diagram.

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